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临床试验/NCT03422016
NCT03422016已完成不适用

The Incidence of Altered Light Responses in Children With Autistic Spectrum Disorders

Great Ormond Street Hospital for Children NHS Foundation Trust4 个研究点 分布在 3 个国家目标入组 177 人开始时间: 2018年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
177
试验地点
4
主要终点
light adapted electroretinogram

研究概览

简要总结

This study aims to find out the incidence of a reduced light adapted electroretinogram (ERG) b-wave amplitude in children with a diagnosis of Autism Spectrum Disorders (ASD).

详细描述

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition which becomes apparent as children grow. Children with ASD are slow to develop language and have problems interacting socially with others. It is not clear why ASD occurs, but there is some evidence that the signals that tell the brain how to grow are altered which causes the brain to develop and function differently in people with ASD. Eyes develop from the same embryonic tissue as the brain. This means that the retina, which is the light sensitive layer at the back of the eye, shares the same signals as the brain. Investigators can listen to retinal signals outside the eye and the retina can, in this way, act as an accessible part of the brain.

The investigators will detect retinal signals as electrical messages. Sensors placed near the eye pick up the electrical changes in the retina each time a light flashes. This non-invasive, routine clinical test is called an electroretinogram, (ERG). The investigators have carried out a study that showed differences in the ERGs recorded from adults with ASD compared to control participants.

The main aim of this project is find out how common ERG differences are in children with ASD compared to controls. If it is common, investigators could use the ERG to make an earlier diagnosis of ASD and help families sooner. It could help investigators better understand the way the ASD brain signals and give investigators a way of measuring if therapies work.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
4 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • cohort 1: individuals with diagnosis ASD with an IQ measure exceeding 85
  • cohort 2: typically developed controls without diagnosis of ASD

排除标准

  • a history of eye disease or treatment or seizure medicines that may alter retinal function

结局指标

主要结局

light adapted electroretinogram

时间窗: 12 months

incidence of reduced light adapted electroretinogram in children with a diagnosis of autism spectrum disorder

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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